title: Randomized comparison between tirofiban and abciximab to promote complete ST-resolution in primary angioplasty: results of the facilitated angioplasty with tirofiban or abciximab (FATA) in ST-elevation myocardial infarction trial.
abstract: OBJECTIVE
  To test the equivalence of high-dose bolus (HDB) tirofiban vs. abciximab during primary percutaneous coronary intervention (PPCI) in terms of ST-segment resolution (STR).
  
  
  RESULTS
  The FATA trial (Facilitated Angioplasty with Tirofiban or Abciximab) was a prospective, multicentre, open-label trial that enrolled 692 patients with ST-segment elevation myocardial infarction (STEMI) undergoing PPCI. Patients were randomized 1:1 to receive abciximab (n = 341) or HDB tirofiban (n = 351). Primary endpoint was the rate of complete (> or =70%) STR 90 min after first balloon inflation. Thirty-day incidence of major bleedings, death, re-infarction and new revascularizations was also evaluated. Baseline characteristics of the two groups were well-balanced, with the exception of previous MI rates (tirofiban 6% vs. abciximab 2.6%, P = 0.03). The procedure was successful in 96.7% of the abciximab and in 96.6% of the tirofiban cohort (P = 0.94). Complete STR was obtained in 67.05% of the tirofiban and 70.45% of the abciximab group (Delta -3.4%, 95% confidence interval -10.35 to +3.56), which falls beyond the predefined Delta +/- 10% equivalence boundaries. Rates of secondary endpoints were similar between the two groups.
  
  
  CONCLUSIONS
  This study failed to show the equivalence of HBD of tirofiban and abciximab as adjunctive therapy to PPCI.
authors.affiliation: Istituto di Cardiologia, Università di Bologna, Policlinico S Orsola-Malpighi, Via Massarenti, 9, Bologna 40138, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Marzocchi
authors.forename: Antonio
authors.initials: A
authors.lastname: Manari
authors.forename: Giancarlo
authors.initials: G
authors.lastname: Piovaccari
authors.forename: Cinzia
authors.initials: C
authors.lastname: Marrozzini
authors.forename: Sebastiano
authors.initials: S
authors.lastname: Marra
authors.forename: Paolo
authors.initials: P
authors.lastname: Magnavacchi
authors.forename: Pietro
authors.initials: P
authors.lastname: Sangiorgio
authors.forename: Lucia
authors.initials: L
authors.lastname: Marinucci
authors.forename: Nevio
authors.initials: N
authors.lastname: Taglieri
authors.forename: Giovanni
authors.initials: G
authors.lastname: Gordini
authors.forename: Nicola
authors.initials: N
authors.lastname: Binetti
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Guiducci
authors.forename: Nicoletta
authors.initials: N
authors.lastname: Franco
authors.forename: Maria Letizia-Bacchi
authors.initials: ML
authors.lastname: Reggiani
authors.forename: Francesco
authors.initials: F
authors.lastname: Saia
mesh_terms: D000077284:Abciximab; D015906:Angioplasty, Balloon, Coronary / Q000379:methods*; D000911:Antibodies, Monoclonal / Q000008:administration & dosage*; D017023:Coronary Angiography; D004305:Dose-Response Relationship, Drug; D054855:Drug-Eluting Stents; D004562:Electrocardiography; D005260:Female; D006801:Humans; D007140:Immunoglobulin Fab Fragments / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000628:therapy*; D015425:Myocardial Reperfusion / Q000379:methods*; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage*; D011446:Prospective Studies; D000077466:Tirofiban; D016896:Treatment Outcome; D014443:Tyrosine / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D000911:Antibodies, Monoclonal; D007140:Immunoglobulin Fab Fragments; D010975:Platelet Aggregation Inhibitors; D014443:Tyrosine; D000077466:Tirofiban; D000077284:Abciximab